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Showing 1 - 3FDA Approves First Biosimilar Product Filgrastim‑Sndz
The U.S. Food and Drug Administration (FDA) today approved filgrastim-sndz (Zarxio), the first biosimilar product approved in the United States. A biosimilar product is a biologic product that is approved based on a showing that it is highly similar to an already-approved biologic. The biosimilar...
FDA Proposes to Extend Its Tobacco Authority to Additional Tobacco Products, Including E-Cigarettes
As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration (FDA) today proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products. ...
FDA Invites Public Input on Menthol in Cigarettes
The U.S. Food and Drug Administration (FDA) has issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking additional information to help the agency make informed decisions about menthol in cigarettes. Despite decades of work to reduce tobacco use in the United States, it continues to be the...
